A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia

Status: Recruiting
Phase: Phase 1
Diagnosis: Pediatric Leukemia
NCT ID: NCT00866281 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients <18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Lewis Silverman, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria: - Mixed-lineage leukemia (MLL) gene rearranged Acute Lymphoblastic Leukemia (ALL), that does not respond to treatment or has relapsed from prior treatment; or FLT3 mutated Acute Myeloid Leukemia (AML) that does not respond to a second treatment or has relapsed from 2 prior treatments - Normal organ function, and chest x-ray - Expected survival greater than 8 weeks - Can care for most of personal needs and perform at least minimum activity Exclusion Criteria: - Patients with symptomatic leukemic central nervous system involvement or isolated extramedullary leukemia - Patients must not have received other treatments for leukemia within a predefined time period, 72 hours for medications, 2 months for transplants - Patients with heart function that is not normal - Patients with HIV or hepatitis - Patients with another severe disease or medical condition besides leukemia Other protocol-defined inclusion/exclusion criteria may apply
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